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The Veteran's Health Administration (VHA) is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders (SCI/D) population. Our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing pressure ulcers (PrUs).
Background:
VHA is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders (SCI/D) population. Our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing pressure ulcers (PrUs).
Objectives:
The goal of the study was to complete activities necessary in preparation for implementing a Home Telehealth program to manage veterans with SCI/D at risk of developing PrUs. Specifically this Rapid Response Project (RRP) included: 1) Convening an expert panel to validate Pressure Ulcer (PrU) PrU DMP items; 2) Developing a standardized protocol that specified how the nurse Care Coordinator who would manage patients who develop open skin wounds across the Hub and Spoke system of care; 3) Assessing individual telehealth DMP items by calling a sample of patients on a daily or weekly basis for up to 2 months to determine their validity and 4) Developing an instrument to assess staff satisfaction with this method of patient management.
Methods:
A convenience sample of veterans about to be discharged home from the Cleveland SCI/D inpatient unit were asked to participate in the study. This included patients living close to the Hub and those referred from spoke sites. Subjects were randomly assigned to receive either daily calls (5 days/week) for 40 total calls, or weekly calls (8 total calls) over the course of the 8 week/2month study intervention period.
Status:
The project team is conducting ongoing analysis of the data to develop publications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily telephone calls | Experimental | Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers |
|
| Weekly telephone calls | Active Comparator | Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily telephone calls | Behavioral | Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Days of Data | Data includes the number of triggered items and types of triggers. | Enrollment to study end, 8 weeks |
| Number of Days With Triggers at Certain Timeframe | Measured the number of days with triggers that occurred on the Baseline day, during the 8-week intervention, and on the End of Study day. | Enrollment to study end, 8 weeks |
| Percent of Participant Triggering DMP Items | Percent of participants who triggered Disease-Management Protocol items by group. | Enrollment to study end, 8 weeks |
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Inclusion Criteria:
- Veterans admitted to Cleveland VA SCI/D unit or treated in the outpatient clinic
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marylou Guihan, PhD MA BA | Edward Hines Jr. VA Hospital, Hines, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois | 60141-5000 | United States | ||
| Louis Stokes VA Medical Center, Cleveland, OH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21756573 | Result | Woo C, Guihan M, Frick C, Gill CM, Ho CH. What's happening now! Telehealth management of spinal cord injury/disorders. J Spinal Cord Med. 2011;34(3):322-31. doi: 10.1179/2045772311Y.0000000003. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Daily telephone calls to remind patients of recommended behaviors Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers. |
| FG001 | Arm 2 | Weekly telephone calls to remind patients of recommended behaviors Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Daily Group | Daily telephone calls to remind patients of recommended behaviors Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers. |
| BG001 | Weekly Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Days of Data | Data includes the number of triggered items and types of triggers. | Posted | Mean | Full Range | days | Enrollment to study end, 8 weeks |
|
Enrollment to study end, 8 weeks.
Study-related serious and non-serious adverse events were collected/assessed, but none observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Daily telephone calls to remind patients of recommended behaviors Daily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers. No adverse events reported. |
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The study duration was short and the sample was small. Because we only studied subjects who received the DMP, it is unknown how many would have had skin breakdown in a comparable period without the DMP.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marylou Guihan, PhD | Center of Innovation for Complex Chronic Health Care | 708-202-2414 | marylou.guihan@va.gov |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Weekly telephone calls | Behavioral | Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers. |
|
| Cleveland |
| Ohio |
| 44106 |
| United States |
Weekly telephone calls to remind patients of recommended behaviors Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Marital status | Number | participants |
|
| Residence type | Number | participants |
|
| Education | Number | participants |
|
| Current employment status | Number | participants |
|
| Years Since Employment | Mean | Full Range | years |
|
| Past Work History | Number | participants |
|
| Duration of Injury in years | Mean | Full Range | years |
|
| Spinal Cord Injury (SCI) Etiology | Number | participants |
|
| Level of Injury | Number | participants |
|
| American Spinal Injury Association (ASIA) Score | Number | participants |
|
| Urinary Management | Number | participants |
|
| Amputees | Number | participants |
|
| Receive regular assistance from: | Number | participants |
|
| Number of prior pressure ulcers (PrU) | Mean | Full Range | pressure ulcers |
|
| Prior Ulcer Locations | It is possible for participants to have >1 ulcer, in multiple locations. | Number | pressure ulcers |
|
| Number of Prior Pressure Ulcer Surgeries | Mean | Full Range | surgeries |
|
| Prior Ulcer Surgery Locations | Number | participants |
|
| Number of Current Pressure Ulcers | Mean | Full Range | pressure ulcers |
|
| Current Pressure Ulcer Location | Number | participants |
|
| Current Pressure Ulcer Stage | Number | participants |
|
| Baseline Self-Reported Skin Behaviors | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Days With Triggers at Certain Timeframe | Measured the number of days with triggers that occurred on the Baseline day, during the 8-week intervention, and on the End of Study day. | Posted | Number | days | Enrollment to study end, 8 weeks | No. of Days with Triggers | Participants |
|
|
|
| Primary | Percent of Participant Triggering DMP Items | Percent of participants who triggered Disease-Management Protocol items by group. | Posted | Number | % of participants triggering an item | Enrollment to study end, 8 weeks | Total Days of Category Trigger | Participants |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Arm 2 | Weekly telephone calls to remind patients of recommended behaviors Weekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers. No adverse events reported. | 0 | 8 | 0 | 8 |
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| D014947 | Wounds and Injuries |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| End of Study Day Triggers |
|
| Positioning/Pressure Reliefs/Weight Shifts |
|
| Skin Moisture Issues |
|
| Existing Pressure Ulcer Care |
|
| Quality of CG Care |
|
| Feelings of Depression |
|
| Ongoing Problems Affecting Self-Mgmt |
|
| Dragging Across Surfaces |
|
| Diabetic Comorbidities |
|